Rigel Pharmaceuticals Inc (RIGL) 2017 Q2 法說會逐字稿

Good afternoon, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Second Quarter of 2017. (Operator Instructions) I would like to remind you that this call is being recorded for replay purposes from Rigel's website. (Operator Instructions)

And now I would like to turn the conference over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel. Ma'am, you may begin.

Hello, and welcome to our Financial Results and Business Update Conference Call. The financial press release for the second quarter of 2017 and the slide presentation for today's call can be viewed in the Investor Relations section of our website at www.rigel.com.

Joining me on the call today from Rigel are Raul Rodriguez, our CEO; Ryan Maynard, our CFO; Anne-Marie Duliege, our Chief Medical Officer; and Esteban Masuda, Senior Vice President of Research.

As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent quarterly report in Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.

At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

Thanks, Dolly, and welcome, everyone. Thank you for your time this afternoon. As you know, likely, this quarter was one where we achieved a major milestone in our transition into a commercial stage biotech company. Now more than ever, we are closer to bringing a new therapeutic option to patients with chronic immune thrombocytopenia, or ITP.

During this call, we will recap our most recent achievements and share why we are very optimistic about the near future.

In June, we announced that the FDA had accepted the NDA we submitted for Tavalisse or fostamatinib disodium in patients with chronic or persistent ITP. We expect the FDA to complete its review by April 17, 2018, under the Prescription Drug User Fee Act also known as PDUFA. As you might imagine, it was quite rewarding to accomplish this significant milestone. It's a credit to our employees and their dedication and hard work.

The NDA included the data from our FIT Phase III clinical program, including the 2 pivotal studies, 047 and 048, as well as the continuing long-term open-label extension study 049. Overall, patients, who responded to fostamatinib, had a timely, robust and an enduring response to treatment. This is important because the rapid response provides an early feedback as to whether fostamatinib may be a viable treatment option for treating a patient with ITP. The robust response allows patients to hold steady platelet counts of about 100,000 per microliter of blood, which will allow for proper clotting.

Fostamatinib may also provide an enduring benefit, with responding patients maintaining their platelet counts for a median duration of 16 months of treatment of fostamatinib, and this number of months is increasing. This data provides confidence that the disease can potentially be controlled in the long term.

As we mentioned before, the FIT Phase III clinical program confirmed that fostamatinib has a consistent and predictable safety profile. This profile aligned with the safety database of over 5,000 patient years.

Now I'd like to ask my colleagues to give you an update on other programs we are working on at Rigel. Besides the ITP program and the NDA submission, I've asked Anne-Marie Duliege to give us an update on our Phase II clinical studies for fostamatinib in IgA nephropathy, as well as our Phase II study for fostamatinib for the treatment of autoimmune hemolytic anemia. This quarter, we also selected a molecule from a IRAK program for the preclinical development. I have asked Esteban Masuda to join us to give us his perspective on the IRAK as a target and moving our candidate into the clinic.

Now I will turn the call over to Anne-Marie and Esteban. Following their presentations, Ryan will report our second quarter financials. Anne-Marie?

Thank you, Raul. First, I want to echo Raul's sentiment in thanking all my colleagues for their ongoing hard work and dedication. It was very rewarding to have the FDA accept our NDA submission, and we look forward to working with the agency and hope to bring this drug -- this new drug to patient population with unmet medical need.

As shown on Slide 9 and 10, Rigel focused on fostamatinib for chronic ITP because there was a significant unmet medical need. There are approximately 65,000 adult patients with chronic ITP in the U.S., and it qualifies as an orphan disease. The chronic ITP patient population is very heterogeneous, meaning that it is challenging to predict which patient will respond to which of the current available treatments, if any.

SYK kinase is a key player in the immune system destruction of platelets in ITP. Fostamatinib is a SYK inhibitor, with a unique mechanism of action. ITP patients can have platelet counts that fall below 30,000, the level at which they are generally considered at risk for spontaneous or trauma-induced hemorrhage. Through our ITP clinical program, we demonstrated that fostamatinib may help certain ITP patients and that the benefit was consistent across all subgroups analyzed, including TPO experienced patients.

On Slide 11, we have reminded you of the design of the Phase III program, 2 similar placebo-controlled trials, where patients were randomized in a 2:1 ratio to fostamatinib at the starting dose of 100 milligram twice a day or placebo. During the trial, patients who did not meet the criteria of 50,000 platelets at week 3 were allowed to dose increase, and those who did not meet this criteria by week 12 were allowed to roll over to the extension study.

On Slide 12, we have summarized the key baseline characteristics. As a reminder, while this is a typical patient population, typical of ITP with the majority of female participants and with a median age of 54, it's also a patient population with chronic severe ITP as shown by a median time since ITP diagnosis of 8.5 years. Patients who have previously been treated by multiple treatments, approximately half of them have received thrombo-receptor agonist, a 1/3 of them were rituximab and another 1/3 of them had splenectomy. And finally, the median baseline platelet count was 16,000, obviously, very low and another sign of the severity of the disease for the patients who participated in the trial.

Slide 13 provides the overall platelets response rate in the combined 047 and 048 study. Here we have outlined not just the stable patients, which were approximately 18%, but also the intermediate patients approximately 11%. The definition of an intermediate platelet response was patient with at least 2 consecutive platelet counts greater than 50,000, of course, in the absence of rescue medication at any time during the controlled trial.

This is important because when assessing which patients benefit from fostamatinib, it is not just the stable responders but also, these intermediate responders, and I will show you why on the next slide.

A total of 29% of -- approximately 30% of patients had some response to fostamatinib compared to 2% in the placebo.

On Slide 14, we provide the median platelet counts over time for each of the subgroups. The stable responders in red have a timely response and robust platelet response that is maintained over time. Indeed, with an increase in average above 50% at week 2, and this increase continues to immediate platelet counts of approximately 100,000 maintained until week 24. The patients with an intermediate response, in green, have also a quick benefit. Their increase is seen as 2 weeks on average, and this benefit is maintained at approximately 50,000 platelets over time to -- from 16,000 to 50,000 platelets. That's a very good outcome for these patients. This is also a clinical benefit for these patients.

On the next slide, Slide 15, we show here the Kaplan-Meier curve of time to first response, which means time to platelet count above 50,000 for those subgroups. It shows that both the stable responders and the intermediate responders have a response as roughly as in 2 weeks to the majority of them, and that they get to a response by about 8 to 12 weeks.

By contrast, the placebo in the nonresponders have a very low platelet count and never get to a median of response.

On the next slide, we show here the critical clinical benefit that these patients have from being treated with fostamatinib in both -- along both the stable responders and the intermediate responders, none of these groups have any serious adverse events of bleeding during the placebo-controlled portion of the study. By contrast, patients who did not have response to fostamatinib, all patients in the placebo group had -- at least a portion of them, had experienced a severe adverse event of bleeding.

Similarly, and that's on Slide 17, patients who met the definition of stable response or intermediate response had a limited need for rescue medications, and in fact, that was essentially during the first week of treatment where they were -- had their platelets increased over time. By contrast, patients who didn't have response are the placebo patients, required more often and more frequently rescue medications.

On the next slide, Slide 18, we provide a summary, and we want to remind you of the adverse events profile of fostamatinib, well defined based on our total experience in ITP, but also having been informed previously by a large database in the RA patient population. Adverse drug reactions are defined as occurring in at least 5% of the fostamatinib patients across both trials, and at least twice as often as in the placebo group. The most frequent reactions are GI symptoms, chronic diarrhea and nausea, as well as hypertension and increases in transaminases.

In summary, the response is consistent across the two Phase III trials with a stable response rate of 18% and a median platelet count of around 85,000 to 100,000 over time. Additionally, 11% of the patients have an intermediate response, with a median platelet count of approximately 50,000 over time, for an overall response rate of nearly 30,000, and this is nearly 30% of the patients.

The responses are similar across subgroups: gender, age, prior treatment or baseline platelets at less or above 15,000. The median time to platelet response is rapid, in dose-responded patients, approximately 2 weeks. There is a lower need for rescue therapy and no bleeding episodes of serious adverse events among the responders. In fact, the adverse events are mostly mild to moderate in severity. And finally, the 049 Study is ongoing and continues to provide us with further evaluation of the long-term safety and efficacy of fostamatinib in ITP.

With the NDA now accepted by the FDA, Slide 20. Slide 20 shows our completed and expected regulatory milestones. To date, our communications with the FDA since the NDA was accepted, have been straightforward and we'll answer their questions as needed. We are also working with our clinical and manufacturing partners to make sure that we're ready for the FDA's expected BIMO and pre-approval inspections, respectively.

We're also preparing for an Oncology Drug Advisory Committee, or ODAC, meeting in the event we have one.

Now I want to spend a bit of time providing an overview of our additional clinical studies of fostamatinib in other indications.

Moving to Slide 21. Raul mentioned our study of fostamatinib in IgA nephropathy. It's a most common glomerulonephritis worldwide. This disease causes inflammation and scarring of the kidney. People with this rare condition are at risk of serious complications from kidney dysfunction, including high blood pressure and renal failure.

We reported results from the first cohort in the Phase II study in January 2017. The primary efficacy endpoint was the mean change in proteinuria from baseline at week 24 shown on Slide 22. The study found that at 24 weeks, fostamatinib was well-tolerated with no new safety signal detected. The initial data suggests a possible trend towards a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo.

On Slide 23, the second cohort shows in the Phase II study is evaluating the efficacy, safety and tolerability on fostamatinib as measured by change in proteinuria, renal function and histology. The second cohort evaluates a higher dose of fostamatinib 150 milligrams twice a day compared to the first cohort, which evaluated the dose of 100 milligram twice a day. And I'm happy to announce that the study has completed the enrollment this week and we will report the results in early 2018.

Finally, Raul also mentioned that our SOAR study continues to enroll. As you will see on Slide 24, there is a large amount -- a large unmet treatment need among patients living with warm autoimmune hemolytic anemia, or AIHA. AIHA is indeed a rare serious blood disorder, where the immune system produces antibodies that result in the destruction of the body's own red blood cells.

The SOAR study is the Phase II study. As outlined on Slide 25, stage 1 of the Phase II study will evaluate the safety and efficacy of fostamatinib at 100 milligram twice a day for 12 weeks in approximately 17 patients with autoimmune hemolytic anemia who've previously received at least one treatment for the disease but have not benefited and are still anemic. Stage 1 is continued enrollment and we expect results from the trial by the end of the year. Stage 2 will have an identical study design and begin enrollment after the stage 1 results are evaluated and reported.

Continuing to our research update, I will now turn the call over to Esteban to discuss our IRAK program. Esteban?

Thank you, Anne-Marie. Today, I'd like to introduce our IRAK inhibitor program, and our Clinical Candidate R509.

In slide 27, why IRAK? IRAK is a regulator of Toll-like receptors, and Toll-like receptors as sensors of tissue damage, are critical in chronic inflammation. IRAK also regulates the receptors for the IL-1 family of cytokines, which are themselves, key mediators of inflammation. Thus IRAK signaling plays a key role in the detection, induction and the mitigation of inflammation, but our preclinical results validated IRAK-1/4 therapeutic targets for inflammatory and autoimmune diseases, including gout, psoriasis and lupus.

In search for inhibitors of Toll receptor signaling, in Slide 28, we use cell-based screens using primary human cells. In doing so, Rigel has discovered and developed IRAK-1/4 inhibitors that completely suppress Toll receptors and IL-1 receptor signaling. Importantly, this complete inhibition, as shown in the left green panel, is associated with potent inhibition of both IRAK-4 and IRAK-1 kinases.

In contrast, inhibitors that block only IRAK-4 and not IRAK-1 are seen in the blue panel exhibit, Partial Inhibition of Cytokine Release. We believe this to be a key differentiation factor between Rigel IRAK-1/4 inhibitors and other programs that inhibit IRAK-4 selectively.

Further characterization of R835, in Slide 29, indicated that it has excellent drug like properties. R835 is a potent inhibitor of IRAK-1 and IRAK-4 kinases in biochemical and cell-based assays. It is potent in numerous animal models of inflammatory disease. It is metabolically stable across several species and possesses good oral bioavailability. R835 is very well tolerated in rat and monkey.

Finally, we have selected R509 as a prodrug of R835 improving its tolerability; where we dose R509 orally, we deliver R835 into the systemic circulation.

R509, in Slide 30, by virtue of inhibiting both Toll receptors and IL-1 receptors has several potential clinical uses. They can be mediated by Toll receptors such as lupus and multiple sclerosis or mediated by IL-1 receptors such as gouty arthritis and pustular psoriasis.

I will show you a couple of examples using animal model effects.

In Slide 31, we show R509 inhibiting a Toll receptor -- Toll-like receptor dependent model of joint inflammation in rats. In the panel below, we see in the blue lines, a dose-dependent inhibition of the onset of disease when dosing of R509 starts with day 0.

Remarkably, R509 also inhibits ongoing disease when dose, in a treatment mode, are shown with a green line, where R509 dosing begins on day 12 when disease has already established. Altogether, these results are consistent with IRAK-1/4 playing a role in both initiating and sustaining chronic inflammation.

In Slide 32, we show R509 inhibiting an IL-1 independent model of gout, which is induced here with -- by intra-articular administration of monosodium urate crystals in the rat joint.

In the left panel below, we can see R509 dose-dependent inhibition of inflammation in the green bars relative to the vehicle in grey. The left color bars are positive controls. In the right panel, R509, also in the green bars, dose-dependently decreases pain sensation relative to the [vehicle in gray], as it is expected when blocking IL-1.

In conclusion, in Slide 33, we are very excited to introduce R509 as a potent IRAK-1/4 inhibitor with proven efficacy in multiple models of chronic inflammation. Currently, work is ongoing to enable the initiation of clinical studies with R509 in the first half of 2018. Thank you.

Now I will turn over the call to Ryan for financial updates.

Thank you, Esteban. For the second quarter of 2017, we reported a net loss of $19.1 million or $0.16 per basic and diluted share compared to a net loss of $13.5 million or $0.15 per basic and diluted share in the same period of 2016.

There were no contract revenues from collaborations in the second quarter of 2017. Contract revenues from collaborations of $8.6 million in the second quarter of 2016 were comprised of $4.8 million from the amortization of the $30 million upfront payment and $95,000 in FTE fees from our license agreement with Bristol-Myers Squibb, as well as payments of $3.7 million that we received from BerGenBio.

We reported total costs and expenses of $19.3 million in the second quarter of 2017 compared to $22.2 million for the same period in 2016. The decrease in costs and expenses was primarily due to the decreases in personnel costs and research-related costs as a result of the reduction in force in September of last year, partially offset by increasing costs related to the preparation for the potential commercial launch of fostamatinib in ITP.

For the 6 months ended June 30, 2017, we reported a net loss of $34.5 million or $0.29 per basic and diluted share compared to a net loss of $31 million or $0.34 per basic and diluted share for the same period of 2016.

As of June 30, 2017, we had cash, cash equivalents and short-term investments of $82.3 million compared to $74.8 million as of December 31, 2016. We expect that these amounts as of June 30, will be sufficient to support our current and projected funding requirements, including the preparation for the potential U.S. launch of fostamatinib through at least the next 12 months. We also continue to evaluate ex U.S. partnerships for fostamatinib and other partnering opportunities across our pipeline.

Back to you, Raul.

Thanks very much, Ryan. And before I turn the call over to your questions, I'd like to provide you a few other updates. With the goal of supporting our upcoming regulatory and commercial launch efforts, we've made numerous hires. And I'd like to just highlight a number of these.

First, Dana Pizzuti, who was Vice President of Regulatory Affairs at Gilead Sciences since 2007 and facilitated the approval of 14 new medicines during her tenure there, joins Rigel as Senior Vice President of Regulatory Affairs and Clinical Quality Assurance. Dana brings tremendous experience across a broad range of regulatory, clinical, NDA and commercial-stage functions. At Gilead, she managed an organization of 500 worldwide and was responsible for regulatory strategies for all of Gilead's approved and investigational new drugs.

Also joining us is Giovanna Matthews. Most recently, she was CEO of LifeWatchCare/ ValidiCare. She joins Rigel as Executive Director, Market Access. Gio has great experience across all the areas of market access and reimbursement, including managed care, specialty pharmacy, distribution, contracting and patient support services. And soon Sandra Tong will join as Vice President, Clinical Sciences and Drug Safety. Most recently, she was Vice President of Clinical Research at Plexxikon. She has over 20 years of clinical development and medical experience in small molecule immunology, oncology and anemia across all stages of development.

Finally, Scott Henley has joined Rigel as Vice President, Clinical Operations. Previously, Scott was Vice President, Clinical Operations, at Titan Pharmaceuticals and has over 17 years of experience in this area. These additions are highly qualified and enthusiastic people, and we're excited to have them join Rigel at this time. We look forward to their contributions. They obviously are very talented, had many choices in terms of places they could go and they chose Rigel. I think it speaks for the opportunity here.

With our NDA submission for fostamatinib accepted and our other studies underway with fostamatinib and other rare diseases and progress made with our IRAK program molecule, I think we've had a very productive quarter. So with that in mind, I'd like to outline for you what will happen at Rigel over the next 9 months: Most importantly, we will work collaboratively with the FDA to review our NDA submission. Secondly, we will continue to build our capabilities to allow us to achieve commercial readiness here in the U.S. We will continue to meet with patients, patient advocates and physicians, who'll help us understand the burden of ITP and the need for new treatment options. As an aside, this past weekend, a team of us from Rigel attended the Platelet Disorder Support Association Annual Meeting in Phoenix. This is a very well-organized patient advocacy organization advocating for patients suffering from ITP. We have a very good relationship with them, and this conference allowed us to hear the patients' side of ITP. And the frustration, the unpredictability and the substantial burden of this disease and how it affects the quality of life of these patients. It was very clear to us that there is a tremendous medical need in this area. It's a really inspiring conference, where you hear that side of the story. So we came back very energized to finish our work with the NDA and move this product into the marketplace.

And finally, we continue to work with other partners to continue develop molecules and move them forward in their pipelines and obviously, as partnership opportunities.

So at this time, I'd like to open up your call -- the call up for your questions.

(Operator Instructions) Our first question comes from Eun Yang of Jefferies.

This is Carmen on for Eun. So regarding the ex U.S. partnership for fostamatinib, what would you need to secure a deal? And by when would you hope to have a partnership in place?

Thanks for the question. So we're having discussions with numerous companies across different geographies. Some are European-focused, some more Asia-focused. I think what we need is progress in terms of the NDA in the U.S. I think that might be a prerequisite, simply because that will provide the final validation that some of these parties would need to sign a deal. As you can imagine, it probably is difficult for some of these parties to sign the deal, ex U.S. with perhaps a substantial amount of money, which is what we would like and still not have the final approval in the U.S. So probably that's a requirement, in terms of that. In Asia -- particularly in Europe. In Asia, the opportunities are little bit different with more of an emphasis on

IgA nephropathy. So I think there -- in addition, they probably would need some results from our

IgA nephropathy Phase II trial, which we will have early next year. So those are probably the 2 major gating issues for deals in those respective territories.

Got it. Great. And then, for the IA -- AIHA indication, how many patients do you expect to have data for and update around year-end? Could that be presented at ASH? And finally, do you expect that the number of patients presented at the end of the year would be sufficient to engage the FDA regarding potential requirements for registration trial? Or if not, when do you expect you would engage the FDA?

Thanks for that question. So we will have 16-or-so patients. 17, I think, is the target by the end of the year. So we expect to have that number. And hopefully, that will give us sufficient data to be able to decide to move forward with autoimmune hemolytic anemia. That will be at the end of the year. It's not going to be for ASH. I think the ASH abstract deadline was this week. And so we're not going to present it at ASH, but we will hope to have that data then. I think we usually put a press release out first week of January, in terms of a pipeline update. So it probably would be part of that update that we give that. And then in terms of FDA engagement, that would follow after that result in our review of the data. So sometime, probably around mid-year, Anne-Marie?

Yes.

Our next question comes from Anupam Rama of JPMorgan.

It's Eric in for Anupam this evening. I guess, coming out of EHA and also the conference that you described earlier, I'm just wondering in terms of some of the precommercial activities you're doing, if you could give us a sense of where do you think Tavalisse is in terms of where it's among hematologists currently, as well as how kind of concentrated the ITP treating physician audience is in U.S.?

Thanks for that question, and we did have a presentation at the European Hematology Association meeting that -- where we reviewed some of the data that you've seen today here now. There was some new data that Anne-Marie presented to you. The PDSA -- at the PDSA meeting, it's more of a bit of different conference. It's really oriented more patients, as well. So it's a bit of a different one than that. It's not the straightforward medical conference like ASH or EHA. In terms of awareness, I think the awareness is still very low in regards to Tavalisse. We haven't really begun to market the product and obviously, won't until sometime next year. So at this point, we're communicating on a medical level at these conferences, and we hope to have some presentations at the ASH meeting at the end of the calendar year to be able to share more with you. Obviously, that isn't -- we submitted, but obviously don't know for certain that, that -- those have been accepted as yet. So we're working towards that. The physician audience that we're targeting is hem/oncs, and we're working on helping identify who the actual prescribers are and that's a step for our commercial team. And they're working hard on that. The folks that I outlined, in terms of joining the company, have that as one of their missions and all the people that are here are working on identifying those physicians and really working on the positioning of the product. Obviously, not yet, but in the near future on the pricing of the product, and we'll be able to communicate that to you. In fact, at a future call -- financial call such as this, I'm going to invite our Head of Commercial Operations to come and give you an update on some of those key activities. So please join us at the subsequent call for that update.

It's very helpful. Maybe just a question here on -- other question on hemolytic anemia with data at year-end. I'm just wondering if you kind of guide us or help us in thinking about the threshold for activity, in terms of hemoglobin response rate or duration of response that you kind of need to see or to be comfortable with advancing that program forward?

So it's actually part of the protocol. We want to see an improvement in hemoglobin, as we are correcting anemia. And want to see at least 10 gram at a minimum and 2 gram above baseline. So this is a criteria that [anyone] would say there is a difference -- maybe a real difference in hemoglobin. Also what we would like to see is clearly a sustainable response, at least for some portion of the 12 weeks duration of the study.

Our next question comes Do Kim of BMO Capital Markets.

It's Alex on for Do. I had a first question going back to the slides. And I was wondering, on slide -- just going back right now, on Slide 14, in the presentation, I was wondering, following the intermediate patients, why over time they seem to decline?

Yes. Very good question, easy. If we had put the end that contributed to the study, you will see that starting from week 18, there is a much more number of patients because some of the patients decide to go directly into an open-label part of the trial. And so this is because the ends are about 3 or 4[in the section] that we see that. That's it.

It's really a factor of that, that we put a little note in there.

Yes.

It's not that they're actually dropping.

It's just a few patients who participate in that and some patients have gone to an open-label extension.

Got you. And then also within ITP -- in light of its IPO, we were wondering sort of bigger picture what management's impression of DOVA Pharmaceuticals' ITP drug was? And if at all, likely effect, probably for the commercial strategy in any way?

I don't -- I'm not in a position to really comment on their drug, but at some point later, I can. I don't think it's a serious difference from what's already available. So I don't think that, that will have a significant bearing on our commercial potential.

Got you. And going over to AIHA, we were wondering with the enrollment, has management identified any bottlenecks to recruiting patients? We know that the 17-patient enrollment has lasted maybe, say, a little longer than expected? And if that's the case, should we expect more expedited enrollment for the phase -- part 2 portion?

I think it is a rare disease, and I think that's one thing we -- given that we worked in ITP, it was hard to recruit the ITP patients. We succeeded. IgA nephropathy was also -- is also a rare disease. And it took us a while. Today, Anne-Marie was able to announce we succeeded there, as well. And the same thing for hemolytic anemia. It's a rare disease. It's -- the patients are not well identified. Many of them have the disease because there is nothing for them. They frankly live in the shadows. And as a result, it's taken a while to have the trial enroll. But I think we've made very good progress, and we'll be able to give you an update on those results at the end of the year. So it's just the nature of where disease is. All of these actually were struggle. And we worked hard. We overcame those struggles and succeeded in completing enrollment.

I'd now like to turn the conference back over to Raul for any closing remarks.

Thank you, and thank you for your questions. The second quarter has been a very good quarter for Rigel. We've made very good progress with our NDA. That was fantastic. That is the most important objective for the company, is to drive that NDA towards an approval early next year. And I think this year was a -- this quarter was a very good quarter, and we continue to work very hard at the many activities related to that. We also are preparing for commercial launch in the U.S. So a great deal of activity related to that: market research, recruiting people in key areas, and we'll give you an update on those activities at the next call. And then, finally, with our IRAK program, I'm delighted to have the -- that molecule selected and the work ongoing to make that molecule -- take that molecule into the clinic next. It's an opportunity that's tremendous and, as Esteban laid out, potential -- in a wide number of potential areas. And that's very exciting to have something with that level of potential and significantly differentiated versus some of the competitors in the IRAK space. I think that's wonderful. So I think it was a very good quarter for the company. I thank you for your continued support and look forward to interacting with you in the future.

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.